BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LOCATOR 3D DELIVERY CATHETER

    MDR report key: 20325336 · Received September 27, 2024

    Report

    Report Number
    3015970743-2024-00003
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 26, 2024
    Manufacturer
    CENTERPOINT SYSTEMS LLC
    Product Code
    DQY
    UDI-DI
    00810024670123
    PMA / PMN Number
    K230363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR PROVIDED A PICTURE OF THE DILATOR WITH "MESH-LIKE TISSUE." IT WAS APPARENT FROM THE PICTURE THAT MESH-LIKE SUBSTANCE WAS THE BRAID-TAIL THAT IS TYPICALLY CUT-OFF DURING THE MANUFACTURING PROCESS. IT IS LIKELY THAT THE BRAID-TAIL WAS FOLDED INTO THE CATHETER DURING A MANDREL REMOVAL PROCESS. CENTER POINT DID A THOROUGH REVIEW OF THE PRODUCTION RECORDS TO DETERMINE IF THERE WERE ANY ABNORMAL OCCURENCES DURING THE MANUFACTURING PROCESS. ALL PRODUCTION RECORDS INDICATED THERE WAS NO PROBLEM DURING MANUFACTURING, THEREBY DEMONSTRATING THIS IS MOST LIKELY AN ISOLATED OCCURRENCE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER THEREFORE NO FINAL DETERMINATION COULD BE MADE. CENTER POINT IMMEDIATELY MADE PRODUCTION PERSONNEL AWARE AND COMPLETED THE INVESTIGATION WITH ALL THE AVAILABLE INFORMATION. ALTHOUGH THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT, ALTHOUGH IT IS HIGHLY UNLIKELY THAT THIS BRAID WIRE COULD BE EXPOSED TO THE PATIENT, CENTER POINT IS REPORTING THIS EVENT OUT OF CAUTION AS EXPOSED BRAIDWIRE SUCH AS THAT INCLUDED IN THE BRAID-TAIL THAT WAS MISTAKINGLY LEFT IN THE SHAFT OF THE CATHETER COULD CAUSE INJURY TO THE PATIENT. NO FURTHER ACTION, INCLUDING REMEDIAL ACTIONS (E.G. RECALL), ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    WHEN THE DOCTOR INSERTED THE GUIDING DILATOR, THERE WAS RESISTANCE AND A MESH-LIKE TISSUE WAS ATTACHED TO THE TIP OF THE DILATOR. DOCTOR'S OPINION: PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684298 CPS LOCATOR 3D DELIVERY CATHETER PERCUTANEOUS CATHETER DQY CENTERPOINT SYSTEMS LLC DS2C200-42 CL12530 00810024670123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown